NA 03.632.401Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10705034719924), received between Dec 12, 2016 and Mar 23, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A L2-PELVIS TRANSFORAMINAL LUMBAR INTERBODY FUSION, THE FINAL TIGHTENING SHAFT FOR OUR MATRIX CONSTRUCT WAS SLIPPING. INSPECTION OF THE TIP LOOKS LIKE IT IS STRIPPED. ALTERNATE SHORT SHAFT WAS USED WITH MINIMAL DELAY. WE ALSO COULD NOT GET THE MIDDLE CAP OF THE #7 CROSS LINK TO TIGHTEN DOWN, SO WE USED A DIFFERENT #7 CROSS LINK WITH MINIMAL DELAY. THERE WERE FRAGMENTS GENERATED AND REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THE SURGERY WAS DELAYED FOR 2 MINUTES AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: MATRIX LOCKING CAP (PART: UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) STRAIGHT TIP T25 DRIVER-LONG. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554392 ↗
• MalfunctionMar 16, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE SPONDYLODESIS REVISION PROCEDURE PERFORMED ON (B)(6) 2020, THE ORTHO KIT "MATRIX 5.5 PREASSEMBLED " INSTRUMENTS WERE USED. DURING THE PROCEDURE THE MATRIX LOCKING CAPS WERE CLOSED WITH THE STRAIGHT TIP T25 DRIVER-LONG. HOWEVER THE AREA OF THE DRIVER AT THE CONNECTION TO THE MATRIX LOCKING CAP BROKE. THE BROKEN FRAGMENT WAS ABOUT 3MM LONG, WHICH COULD EASILY BE REMOVED WITH TWEEZERS. THEN THE T25 STARDRIVE SHAFT FOR MATRIX STANDARD WAS USED AS AN ALTERNATIVE INSTRUMENT. THE REMAINING LOCKING CAPS COULD BE LOCKED WITH THIS INSTRUMENT, BUT THE INSTRUMENT WAS UNUSABLE AT THE END BECAUSE THE STAR DRIVE PROFILE OF THE DRIVE OF THIS SCREWDRIVER WAS WORN OUT. THIS ASSESSMENT WAS DONE BY TESTING A LOCKING CAP THAT WAS ALREADY LOCKED WITH TORQUE AND SUBSEQUENTLY CONFIRMED. ADDITIONALLY THERE WAS A ISSUE WITH TWO (2) TORQUE HANDLES. THE TORQUE HANDLES WERE SO DIFFICULT TO MOVE THAT IT WAS IMPOSSIBLE FOR THESE INSTRUMENTS TO GUARANTEE THE SPECIFIED TORQUE LIMIT OF 10 NM. PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE SURGERY WAS NOT DELAYED. THIS REPORT IS FOR ONE (1) STRAIGHT TIP T25 DRIVER-LONG. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11497472 ↗
• MalfunctionMar 8, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY WHEN FINAL TIGHTENING IT WAS TROUBLED WITH THE DISTAL PART BEING TORN . WHEN TIGHTEN THE INNE SCREW OR SLIP/LOSES ITS GRIP IN THE TIGHTENING. THE SURGERY WAS EXTENDED FOR 15 MINUTES. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) . STRAIGHT TIP T25 DRIVER-LONG. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440498 ↗
• MalfunctionFeb 16, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON WAS PERFORMING A L3-L5 POSTERIOR FUSION USING THE MATRIX SYSTEM. HE WAS FINAL TIGHTENING THE CONSTRUCT WITH THE TORQUE LIMITING HANDLE AND THE STRAIGHT T25 SHAFT, WHEN THE TORQUE LIMITER SEEMED TO NOT CLICK OR RELEASE AT THE RIGHT PRESSURE AND THE TIP OF THE SHAFT BROKE OFF IN THE LOCKING CAP. SURGEON REMOVED THE FRAGMENT AND REQUESTED ANOTHER SHAFT AND HANDLE. ANOTHER WAS PROVIDED AND AFTER A DELAY OF ABOUT 3-4 MINUTES, SURGEON PROCEEDED WITHOUT ANY FURTHER ISSUES. NO KNOWN HARM WAS CAUSED TO THE PATIENT. CONCOMITANT DEVICE REPORTED: MATRIX LOCKING CAP (PART: 09.632.099; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) STRAIGHT TIP T25 DRIVER-LONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11333866 ↗
• MalfunctionFeb 8, 2021Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, WHEN PERFORMING A T8-PELVIS FUSION USING THE MATRIX SPINE SYSTEM, THERE WAS AN ISSUE WITH THE 10NM TORQUE LIMITING RATCHET HANDLE. THE SURGEON WAS FINAL TIGHTENING THE LOCKING CAPS WITH THE 10NM TORQUE LIMITING RATCHET HANDLE, BUT SCREWDRIVER SHAFT WAS NOT WORKING PROPERLY. THERE WAS NO HARM TO THE PATIENT AND THE DELAY IN SWITCHING TO THE WORKING HANDLE WAS APPROXIMATELY 1 MINUTE. LATER IN THE SAME CASE, THE SURGEON WAS APPLYING A TRANS CONNECTOR WITH THE PROPER SHAFT AND HANDLE, AND THERE WAS A PROBLEM WITH THE IMPLANT. ONE OF THE SCREWS WAS NOT ENGAGING PROPERLY. IT WOULD TURN BUT WOULD NOT TIGHTEN. USED ANOTHER TRANS CONNECTOR AND THAT ONE WAS IMPLANTED PROPERLY WITH NO ISSUE. THERE WAS NO HARM TO THE PATIENT AND THE DELAY TO SWITCH TO THE NEW IMPLANT WAS APPROXIMATELY 30 SECONDS. CHANGED DEVICE AND/OR IMPLANT, NOTHING BROKE OFF, ITEMS JUST DIDN'T PERFORM AS INTENDED, THERE WAS A 1.5 SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: MATRIX LOCKING CAP (PART: 09.632.099;LOT# UNKNOWN; QUANTITY: 1), 10NM TORQUE LIMITING RATCHET (PART:03.620.061;LOT# UNKNOWN; QUANTITY: 1), HOLDING SLEEVE (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11298268 ↗
• MalfunctionJun 6, 2019Device Damaged by Another Device; Device Damaged by Another Device

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE, AS THE SURGEON WAS COMPLETING THE FINAL TIGHTENING OF AN UNKNOWN SCREWS ON AN INSTRUMENTED FUSION CASE, THE SCREW SHAFT WAS SHEARED OFF INTO THREE (3) PIECES. ALL PARTS THAT WERE SHEARED OFF WERE RECOVERED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8676518 ↗
• MalfunctionFeb 5, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A ROUTINE INSPECTION IN STERILE PROCESSING DEPARTMENT (SPD) FOR PROCESSING, IT WAS NOTICED THAT THERE WAS SOMETHING ABNORMAL ABOUT A SCREWDRIVER SHAFT STARDRIVE, T25, LONG, STRAIGHT TIP, WITH HEXAGONAL COUPLING, FOR MATRIX. THE THREADS ON THE DISTAL END OF THE SHAFT ARE WORN DOWN AND ALL STOP AT THE SAME POINT ON THE SHAFT JUST BEFORE THE END. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) STRAIGHT TIP T25 DRIVER-LONG . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8306959 ↗
• MalfunctionJun 15, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A 2 LEVEL TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) AT L4-S1 USING THE MATRIX SYSTEM. DURING THE FINAL TIGHTENING OF THE LOCKING SCREW ON THE LEFT SIDE OF L5, THE SCREW DRIVER SHAFT BROKE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ANOTHER SCREW DRIVER WAS TAKEN FROM THE SET AND WAS CONNECTED TO THE TORQUE LIMITING HANDLE THAT WAS PREVIOUSLY USED. THE SET SCREW WAS THEN FINALLY TIGHTENED WITH NO ISSUE. THE SURGEON THEN FINALLY TIGHTENED THE LAST REMAINING SCREW IN THE CONSTRUCT AND THE PROCEDURE WAS CONTINUED AS PLANNED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO REPORTED DELAY. THERE WAS NO REPORTED HARM TO THE PATIENT. CONCOMITANT MEDICAL PRODUCTS: 10NM TORQUE LIMITING RATCHET HANDLE ¿ 6MM HXC (PART: 03.620.061, LOT: UNKNOWN, QUANTITY: 1); MATRIX LOCKING CAP WITHOUT SADDLE (PART: 09.632.099, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A STRAIGHT TIP T25 DRIVER-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7605563 ↗
• MalfunctionMay 14, 2018Break; Break

  IT WAS REPORTED THAT THE WORKING TIP OF A LONG STRAIGHT TIP T25 STAR DRIVER BROKE ON (B)(6) 2018. THERE WAS NO PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION AVAILABLE. THIS REPORT IS FOR A STRAIGHT TIP T25 DRIVER-LONG. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7512006 ↗
• MalfunctionNov 10, 2017Break; Break

  IT WAS REPORTED THE TIP OF THE SHAFT OF THE T-25 SCREWDRIVER BROKE INTO THREE PIECES WHEN THE SURGEON WAS TIGHTENING IT AT THE END OF THE ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE ON (B)(6) 2017. THE SURGEON SUCCESSFULLY REMOVED ALL THE PIECES WITH NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER READILY AVAILABLE SCREWDRIVER. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO DELAY AND NO HARM TO THE PATIENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. CONCOMITANT DEVICES REPORTED: LOCKING CAP (PART # 09.632.099, UNKNOWN LOT #, QUANTITY # 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7022456 ↗
• MalfunctionMay 9, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT THE STRAIGHT TIP DRIVER LONG SCREWDRIVER WAS STRIPPED DURING A POSTERIOR LUMBAR INTERBODY FUSION (PLIF) PROCEDURE AT AN UNKNOWN LEVEL ON (B)(6) 2017. DURING FINAL TIGHTENING OF A LOCKING CAP, THE SCREWDRIVER WAS SLIPPING AND IT WAS DISCOVERED THAT THE SCREWDRIVER WAS STRIPPED AT THE END. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE SURGERY WITH NO DELAY. CONCOMITANT DEVICES REPORTED: LOCKING CAP (PART #: UNKNOWN, LOT #: UNKNOWN, QTY. 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6555867 ↗
• MalfunctionMar 31, 2017Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY ON (B)(6) 2017 FOR A TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF), LEVEL L4-5, AND DURING FINAL TIGHTENING OF THE LOCKING CAPS, THE SCREWDRIVER STRIPPED. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO COMPLETE THE TIGHTENING WITHOUT ANY PROBLEMS AND IT WAS UNCLEAR IF HE WAS AWARE OF THE ISSUE. THE STRIPPED SCREWDRIVER WAS FOUND POST OPERATIVELY WHEN CLEANING UP THE INSTRUMENTS. THE PATIENT WAS IMPLANTED WITH AN INTERBODY SPACER, 2 RODS, 4 PEDICLE SCREWS AND 4 LOCKING CAPS. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT DELAY, AND THE PATIENT REPORTED AS STABLE. CONCOMITANT DEVICES: MATRIX LOCKING CAP WITHOUT SADDLE (PART #09.632.099, LOT #UNKNOWN, QUANTITY 4). THIS COMPLAINT IS FOR ONE (1) SCREWDRIVER THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6449638 ↗
• MalfunctionDec 12, 2016Break; Break

  IT WAS REPORTED THAT THE TIP OF A STARDRIVE SCREWDRIVER WAS FOUND BROKEN OFF DURING INSPECTION OF THE SET. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Patient Involvement

  MAUDE report 6167464 ↗